Problem Report Form
PTMS WILL PERMANENTLY CLOSE TO NEW SUBMISSIONS ON DECEMBER 20, 2018. WHEN USING CNS IRB GUIDANCE AND TEMPLATES, PLEASE REMEMBER THAT IRB SUBMISSIONS AFTER DECEMBER 24, 2018 WILL BE THROUGH IRIS.
The Problem Report Form is generated in PTMS when the “Problem” action is selected. The
Problem Report Form is used to report
Unanticipated Problems (UPs),
Adverse Events (AEs)
Serious Adverse Events (SAEs),
If the same event fits more than one reportable category,
a single action can be used. When completing the Problem Report in PTMS,
select all applicable problem types (UP, PD, AE/SAE, and/or Non-Compliance).
The Problem Report form asks for a description of the problem and corrective actions.
Unanticipated Problem (UP)
An Unanticipated Problems is any incident, experience, or outcome that meets ALL of the following criteria:
Unexpected – in terms of nature, severity or frequency
Related or possibly related – – to participation in the research. Relatedness for serious events should be determined by the PI in consultation with the Institute Clinical Director
Suggests that the research places the subject or others at a greater risk of harm– including physical, psychological, economic, or social harm
Adverse Event (AE),
including Serious Adverse Event (SAE)
An Adverse Event is any untoward medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in research, whether or not considered related to the subject’s participation in the research. In context of the FDA-required reporting, an AE means any untoward medical occurrence associated with the use of a drug in human, whether or not considered drug related.
A Serious Adverse Event is any AE that 1) results in death, 2) is life threatening, 3) results in inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability, 5) results in a congenital anomaly/birth defect, or 6) may jeopardize the subject’s health.
A Protocol Deviation is any change, divergence, or departure from the IRB-approved research protocol.
Non-Compliance is the failure to comply with applicable NIH HRPP policies, IRB requirements, or regulatory requirements for the protection of human research subjects, which can be serious and continuing.
NOTE: No changes to the protocol or consent/assent forms are allowed with the submission of the problem report. If modifications are needed in response to a problem, an amendment must be submitted to address those changes. The only exception is that investigators may take whatever steps are necessary to prevent IMMINENT HARM to a participant.
If the described problem was reviewed by the Institute, study monitor, DSMB, or others, their report should be submitted. Report documentation should be uploaded into “PTMS” under the “Supporting Documents” heading.
- Problem Report form (completed in PTMS)
- Protocol (latest IRB-approved version)
- Consent/Assent Forms (.pdf’s from the CC Website)
Additional documents that are required, as applicable:
- Corrective Plan of Action
- FDA Documents/Correspondence
- Data and Safety Monitoring Committee Report
- Audit Report
- Root Cause Analysis
- Participant Correspondence
For information on how to upload an attachment in PTMS, consider taking the PTMS training course,
or contact the PTMS liaison for PTMS-related questions.